BEUDAMED
    FDA Recall Terminated

    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.

    Recall: Z-2051-2020 · Initiated April 20, 2020

    Recall

    Recall Number
    Z-2051-2020
    Event Number
    85509
    Firm
    Cardinal Health Inc.
    FEI Number
    3004008697
    Product Code
    PQZ
    Status
    Terminated
    Root Cause
    Storage
    Initiated
    April 20, 2020
    Terminated
    July 23, 2020
    Address
    7000 Cardinal Pl, Dublin, OH, 43017-1091

    Description

    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.

    Reason

    Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.

    Action

    On April 20, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that the product had been incorrectly stored and that there was a potential for misdiagnosis. Action Required: 1. CHECK all storage and usage locations to confirm whether you have any units of the affected product codes and lot numbers containing the labeling outlined in the letter. 2. SEGREGATE and QUARANTINE all on-hand affected product. 3. PLEASE RETURN the letter's acknowledgment form via facsimile (847-689-9101 or 614-652-9648) or email ([email protected]) and indicate the product code, lot and quantity of product youve quarantined or discarded. Please respond regardless of whether or not you have affected product. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST: " Hospital800-964-5227 " Federal Government800-444-1166 " Distributor800-635-6021 " All other Customers888-444-5440

    Distribution

    US Nationwide distribution NC, KS, and AL.